FDA 510(k) Application Details - K151481

Device Classification Name	More FDA Info for this Device
510(K) Number	K151481
Device Name	Sahara Stabilization System
Applicant	K2M, INC 751 MILLER DRIVE SE LEESBURG, VA 20175 US Other 510(k) Applications for this Company
Contact	NANCY GIEZEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2015
Decision Date	12/21/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review